510(k) Report

FDA applicant

Medibio USA, LLC

Cooper City, FL1 decision2018–20180 recalls

FDA records 1 decision for Medibio USA, LLC (Cooper City, FL) in 2018: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Medibio USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Medibio USA, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen1decision

What has FDA decided for it lately?

  • K180720Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 BevelMedibio USA, LLC · 2018

The one decision as Medibio USA, LLC →